Job Summary: The Clinical Research Coordinator II’s primary responsibilities are to screen, enroll and follow study subjects ensuring protocol and regulatory compliance and close monitoring while subjects are in study. Due to enhanced experience at FRI the Clinical Research Coordinator II will assume a greater study workload, overall study responsibility, and stronger Sponsor and CRO interaction, while conveying a positive image of FRI to community, sponsors, CRO’s and study participants and family members.

Our Culture: Inspire hope. Build your legacy. Founded in 2011, Florida Digestive Health Specialists (FDHS) is the state's largest single-specialty, physician-owned gastroenterology practice. FDHS provides unparalleled, compassionate gastroenterology care. With a mission to provide the highest quality digestive health services while fostering advanced research to improve patient outcomes, FDHS offers comprehensive care across 30 locations in Florida. The team includes many “Top Doctors” recognized by Castle Connolly for their clinical excellence and dedication to the communities they serve. This is a great organization to be a part of, so come join the team!

Duties include but are not limited to:

Study Preparation:

• Review and assess protocol (including amendments) for clarity, logistical feasibility, subject safety, and inconsistencies, etc.
• Discuss study medication, required procedures, eligibility criteria and impact on office flow with investigators and staff
• Assist with planning and creation of appropriate recruitment materials
• Assist in development of recruitment plan and obtain listing of potential candidates to contact from database
• Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies
• Participate in Investigator’s meeting and /or coordinate pre-study site visit with clinical staff and Sponsor/CRO representatives
• Create (or review sponsor provided) protocol specific source documents
• Determine facility, equipment and outsource vendor availability
• Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
• Ensure education of staff and/or sub-investigators is completed for required tasks

Study Management:

• Integrate new trial load with existing trial load and prioritize activities with regard to protocol timelines
• Maintain organized files for blank source documents, patient charts, CRFs and supplies
• EDC entry of required visits within 72 hours of visit elements being completed
• Investigational product accountability: receive, inventory, dispense, monitor patient compliance, and re-order as necessary. Document on accountability log and patient records
• Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during these meetings
• Ensure trial activities are discussed in advance with covering personnel in case of vacation or sick leave
• Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
• Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of FRI team in an ongoing fashion
• Develop and maintain effective relationships with study participants and FRI personnel
• Complete End of Study Packets for Patient Liaisons
• Interact in a positive, professional manner with patients, sponsor representatives, offices/investigators, and FRI personnel
• Communicate clearly verbally and in writing
• Accept accountability for actions and function independently

Patient Coordination:

• Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment
• Contact scheduled Screening patients 72 hours prior to Screening appointment to verify pre-screened information has not changed
• Obtain informed consent per FRI SOP and document process. When revised ICF is received and discussed with patients during the trial adequate documentation required
• Complete visit procedures and ensure proper specimen collection processing and shipment in accordance with protocol and lab manual
• Be prepared to complete basic clinical procedures, such as blood draws, vital signs, and ECGs
• Review laboratory results, ECGs, and other test results (e.g., biopsy results) for completeness and alert values, ensure investigator review in a timely fashion
• Recognize adverse events (AES) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator, Sponsor, and site regulatory coordinator. Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol
• Schedule patients within visit windows (including any outside procedures-MRI, biopsy, etc.), notify personnel as needed for procedures, and integrate visits with existing schedule to maximize efficient workflow and patient turnaround
• Dispense study medication per protocol and or IVRS system. Educate patient on proper administration and importance of compliance
• Monitor patient progress on study medication

Documentation:

• Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP
• Accurately record study medication inventory, medication, dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmations are conducted in a timely fashion
• Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart
• Accurately transcribe data to CRFs. Resolve data management queries and correct source data as needed
• Record protocol exemptions and deviations as appropriate with sponsor - Complete Memo to File for patients’ charts and regulatory filing if necessary
• Ensure all sponsor correspondence (emails, telephone conversations) are printed and given to appropriate personnel for regulatory filing
• Maintain copies of patient-specific correspondence in source charts
• Assist regulatory personnel with completion of continuing/final review reports
• Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all- inclusive.

Knowledge, Skills, and Abilities:

• Good working knowledge of medical and research terminology
• Enhanced working knowledge of federal regulations, good clinical practices (GCP)
• Ability to mentor and guide less experienced CRCs as they develop and gain experience
• Ability to communicate and work effectively with a diverse team of professionals
• Excellent organizational, prioritization and leadership skills and capabilities
• Strong computer skills with demonstrated abilities using clinical trials database, electronic data capture, MS Word, and Excel
• Excellent interpersonal skills, detailed-oriented and meticulous
• Excellent professional writing and communication skills
• Ability to work independently in a fast-paced environment with minimal supervision

Experience:

• Three years clinical research experience
• Three years Clinical Research Coordinator experience
• A minimum of one year as a FRI Clinical Research Coordinator I or completion of FRI CRC competency form

License/Certification:

• RN or LPN preferred
• Research Professional Certificate- CCRC or exam eligibility preferred

When you join FDHS, you become part of a premier team striving to deliver unparalleled, personalized care while treating patients like family. And at FDHS, our patients are at the heart of everything we do. Join our team at FDHS and make a difference in the lives of our patients and employees alike!